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Bioanalytical Lab Manager

Company: Arrowhead Pharmaceuticals
Location: Madison
Posted on: March 19, 2023

Job Description:

The PositionInitially, the Lab Manager will assist in the set up and implementation of a GLP lab. Once the GLP lab is established, the Lab Manager will lead a team of scientists in regulated method validation and sample analysis in support of GLP toxicokinetic and GCP pharmacokinetic studies. The lab manager will have expertise with LC-MS and HPLC-FL analytical platforms and is well versed in regulated bioanalysis. The lab manager will establish and lead bioanalytical training and provide expertise to less experienced scientists. The lab manager will be joining a team of highly motivated and experienced scientists and will contribute to the success of Arrowhead development programs. - -Responsibilities

Assist with the set up and implementation of a GLP lab to support regulated method validations and sample analysis, including LIMS setup, IQ/OQ/PQs and calibrationsHelp set up/review SOPs and templates related to GLP bioanalysisBuild and lead a team to support internal regulated bioanalysisLead and mentor a team of bioanalytical scientists, providing technical and career development guidance, including managerial duties such as performance goals, reviews and talent developmentDevelop a training program and lead training of junior scientistsEnsure work is compliant per GLP/GCP regulatory requirements and stay up-to-date on relevant regulationsLead method validations of bioanalytical assays via HPLC-FL and LC-MS/MS, evaluate assay and instrument performance, ability to troubleshoot issuesLead lab organization and maintain instrumentationConduct peer review of data, protocols and reportsEffectively manage workload and monitor and evaluate team completion of tasks and projectsWorks collaboratively with cross-functional teams (PM, Clinical, DMPK, QA, QC, Regulatory and others as needed) to develop and meet project goals, deliverables, and timelinesTrack progress against project -timelines, generate regular status updates, and communicate progress and issues to management and cross-functional teamsMulti-task across several projects and manage time effectively to achieve resultsAdhere to safe laboratory practicesRequirements:
  • Minimum BS degree with 10+ years or MS with 7+ years or PhD with 5+ years of relevant experience in the pharmaceutical/CRO industry
  • Demonstrated method development experience with various analytical platforms and deep expertise with LC-MS and LC-FL
  • Demonstrated project and time management
  • Experience leading and training other scientists and leading lab organization and processes -
  • Good documentation practices with excellent organization and attention to detail
  • Demonstrated innovation, creativity and resilience in problem solving
  • Excellent oral and written communication skills
  • Self-motivated team player with the ability to thrive in a fast paced, dynamic, multi-disciplinary, matrixed environment -Powered by JazzHR

Keywords: Arrowhead Pharmaceuticals, Madison , Bioanalytical Lab Manager, Healthcare , Madison, Wisconsin

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